WASHINGTON, D.C. — The Food and Drug Administration (FDA) has issued a safety notice to health care providers regarding the use of Mega 2000 and Mega Soft Patient Return Electrodes by Megadyne Medical Products, Inc. This action, taken in collaboration with Health Canada, follows reports of burn injuries linked to these devices.
Since June 2023, Megadyne has initiated four voluntary recalls of various product codes of Mega 2000 and Mega Soft Patient Return Electrodes. These recalls are due to reports of burn injuries in both pediatric and adult patients, as well as health care providers. Some burns have been severe, requiring medical intervention and potentially leading to prolonged hospital stays and additional surgeries.
The FDA advises that the Mega Soft Pediatric Patient Return Electrodes (product code 0840) should not be used on any patients. Other recalled products, including Mega 2000 and Mega Soft Patient Return Electrodes (product codes: 0800, 0830, 0835, 0845, 0846, 0847, and 0848), should only be used on patients aged 12 years and older, despite existing labels indicating suitability for younger patients.
These electrodes are used during monopolar electrosurgery to conduct electrical energy from the target tissue back to the electrosurgical unit. However, issues with these devices have led to harmful outcomes, prompting the recalls and updated usage guidelines.
“Following these recall instructions is critical to ensuring the safe use of these products,” the FDA emphasized. Healthcare providers are urged to review Megadyne’s recall notifications and abide by the updated instructions for use.
The FDA continues to work closely with Megadyne to ensure awareness of the recalls, update the product labeling, and monitor device performance. Providers are encouraged to report any problems with the electrodes to the FDA.
The FDA will maintain open communication with healthcare providers and the public as new information or recommendations become available. This ongoing vigilance is part of the FDA’s commitment to medical device safety and patient care.
For the latest news on everything happening in Chester County and the surrounding area, be sure to follow MyChesCo on Google News and MSN.